On Wednesday, April 16, we took part in one of the most important conferences in our industry – BKWM 2025, dedicated to clinical investigations of medical devices. The event was full of expert insights, meaningful dialogue, and valuable networking.

The BKWM – Clinical Investigations of Medical Devices Conference has become a key annual gathering for regulators, manufacturers, sponsors, and clinical trial professionals. This year, Pure Clinical not only actively participated but also proudly took part as a sponsor, supporting open dialogue and professional knowledge exchange.

Thought leadership from Pure Clinical

Representing Pure Clinical and MDR Regulator at the conference were: Dr. Małgorzata Pawlikowska, Katarzyna Wesołowska, Agnieszka Czapko, Fryderyk Janiak, and Adam Sobantka.

One of the highlights was the presentation by Dr. Małgorzata Pawlikowska, titled:

“Products used in aesthetic medicine in light of MDR requirements – regulatory challenges and clinical studies.”

The session sparked broad interest and led to continued discussions during networking breaks.

Where knowledge meets practice

BKWM 2025 enabled not only expert-level presentations, but also in-depth exchanges of experience between attendees. The Pure Clinical team was active in panels and conversations, sharing insights and exploring key industry challenges.

Three standout sessions included:

AI-based device certification and data quality – with input from TUV NORD and legal experts on regulatory and practical implications,
Clinical data requirements for Class I devices – focusing on the transition from MDD to MDR and the perspective of sponsors and manufacturers,
URPL’s coordinated assessment process – a clear and practical guide to regulator expectations and submission strategy.

Thank you for the opportunity

We thank the organizers – the Polish Association for Good Clinical Practice (GCPpl) and Fairfield Legal – for creating such a well-organized and thought-provoking event.

We were proud to co-create BKWM 2025 as a sponsor and look forward to next year’s edition!